[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's discussion and analysis, market risk disclosures, and internal controls for the period [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed financial statements for the period ended September 30, 2022, show a net loss of **$37.3 million** for the nine-month period, an increase from **$32.4 million** in the prior year period, driven by higher research and development and general administrative expenses. The company's cash, cash equivalents, and investments decreased to **$85.9 million** from **$122.2 million** at the end of 2021, primarily due to cash used in operating activities. The company has no revenue and continues to fund operations through equity financing [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) The balance sheet reflects a significant decrease in total assets, primarily driven by a reduction in cash and cash equivalents Condensed Balance Sheet Data (in thousands) | Account | September 30, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $61,163 | $122,222 | | Short-term investments | $24,732 | $0 | | Total current assets | $88,175 | $124,541 | | **Total Assets** | **$91,675** | **$126,336** | | **Liabilities & Equity** | | | | Total current liabilities | $5,801 | $8,380 | | Total stockholders' equity | $85,874 | $117,956 | | **Total Liabilities and Stockholders' Equity** | **$91,675** | **$126,336** | - Total assets decreased by **27.4%** from December 31, 2021, to September 30, 2022, primarily due to a significant reduction in cash and cash equivalents used to fund operations[14](index=14&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements show an increased net loss for the nine-month period, primarily due to rising research and development and general and administrative expenses Condensed Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $8,216 | $8,169 | $26,900 | $22,575 | | General and administrative | $3,562 | $3,394 | $10,937 | $9,845 | | **Total operating expenses** | **$11,778** | **$11,563** | **$37,837** | **$32,420** | | Loss from operations | $(11,778) | $(11,563) | $(37,837) | $(32,420) | | **Net loss** | **$(11,427)** | **$(11,560)** | **$(37,283)** | **$(32,401)** | | Net loss per share | $(0.39) | $(0.45) | $(1.29) | $(1.31) | - For the nine months ended September 30, 2022, the net loss increased to **$37.3 million** from **$32.4 million** in the prior-year period, driven by a **19.2%** increase in R&D expenses and an **11.1%** increase in G&A expenses[17](index=17&type=chunk) [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash flow statements indicate a significant increase in cash used for operations and a substantial decrease in cash provided by financing activities Condensed Statements of Cash Flows (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(34,249) | $(23,594) | | Net cash (used in) provided by investing activities | $(26,901) | $5,150 | | Net cash provided by financing activities | $91 | $35,275 | | **Net (decrease) increase in cash and cash equivalents** | **$(61,059)** | **$16,831** | | Cash and cash equivalents—end of period | $61,163 | $118,260 | - Cash used in operating activities increased by **45%** year-over-year for the nine-month period, reflecting higher net loss and changes in operating assets and liabilities. Financing activities provided minimal cash in 2022 compared to **$35.3 million** in 2021, which included proceeds from stock issuance[28](index=28&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) These notes provide critical context on the company's business model, financial position, liquidity outlook, and significant post-period events including a new license agreement and lawsuit dismissal - The company is a clinical-stage biotechnology firm focused on engineered T cell therapies for autoimmune diseases and does not expect to generate revenue until a product candidate is approved and commercialized[31](index=31&type=chunk)[33](index=33&type=chunk) - As of September 30, 2022, the company had cash, cash equivalents, and investments of **$85.9 million** and an accumulated deficit of **$149.9 million**. Management believes current cash will fund operations for at least **12 months** from the filing date[34](index=34&type=chunk)[35](index=35&type=chunk) - Subsequent to the quarter end, on October 7, 2022, the company entered into an exclusive license agreement with Nanjing IASO Biotherapeutics, involving a **$2.5 million** upfront payment and potential future milestones up to **$162 million**, plus royalties[93](index=93&type=chunk) - A shareholder class action lawsuit filed in February 2022, alleging misleading statements regarding the DesCAARTes™ trial, was voluntarily dismissed by the plaintiff on October 17, 2022[75](index=75&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing engineered T cell therapies through its CABA™ platform, including CARTA and CAART approaches. The lead CARTA candidate, CABA-201, targets a broad range of autoimmune diseases, while the lead CAART candidate, DSG3-CAART, is in a Phase 1 trial for mPV. For the nine months ended September 30, 2022, R&D expenses increased to **$26.9 million** and G&A expenses rose to **$10.9 million**, contributing to a net loss of **$37.3 million**. The company believes its existing cash of **$85.9 million** will fund operations through the second quarter of 2024 but will require substantial additional financing for future development and commercialization [Business Overview and Pipeline](index=24&type=section&id=Business%20Overview%20and%20Pipeline) This section details the company's clinical-stage focus on engineered T cell therapies for autoimmune diseases, highlighting key candidates and their development status - Cabaletta is a clinical-stage company focused on engineered T cell therapies for autoimmune diseases, utilizing two platforms: CARTA (chimeric antigen receptor T cells for autoimmunity) and CAART (chimeric autoantibody receptor T cells)[97](index=97&type=chunk) - The lead CARTA candidate, CABA-201, is a CD19-CAR T therapy with potential across diseases like SLE, rheumatoid arthritis, and myositis. The company obtained an exclusive license for its CD19 binder from IASO in October 2022[97](index=97&type=chunk)[98](index=98&type=chunk) - The lead CAART candidate, DSG3-CAART, is in the DesCAARTes™ Phase 1 trial for mucosal pemphigus vulgaris (mPV). The company is prioritizing a combination sub-study with pre-treatment to follow the A5 cohort[99](index=99&type=chunk)[101](index=101&type=chunk) - The MuSK-CAART program for myasthenia gravis received FDA fast track and orphan drug designation, with plans to initiate the MusCAARTes™ trial in Q4 2022[101](index=101&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section analyzes the drivers behind the company's increased net loss, specifically focusing on the rise in research and development and general and administrative expenses Comparison of Operating Results (in thousands) | Period | R&D Expense | G&A Expense | Net Loss | | :--- | :--- | :--- | :--- | | **Three Months Ended Sep 30, 2022** | $8,216 | $3,562 | $(11,427) | | **Three Months Ended Sep 30, 2021** | $8,169 | $3,394 | $(11,560) | | **Nine Months Ended Sep 30, 2022** | $26,900 | $10,937 | $(37,283) | | **Nine Months Ended Sep 30, 2021** | $22,575 | $9,845 | $(32,401) | - For the nine months ended Sep 30, 2022, R&D expenses increased by **$4.3 million** year-over-year, primarily due to a **$3.2 million** increase in personnel costs from higher headcount and a **$1.3 million** increase in clinical trial costs for the DesCAARTes™ and MusCAARTes™ trials[131](index=131&type=chunk) - General and administrative expenses for the nine months ended Sep 30, 2022 increased by **$1.1 million** year-over-year, driven by a **$1.2 million** rise in personnel costs and a **$0.5 million** increase in administrative costs, partially offset by lower D&O insurance[133](index=133&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's cash position, accumulated deficit, and projected liquidity runway, along with past and potential future financing activities - As of September 30, 2022, the company had **$85.9 million** in cash, cash equivalents, and investments, with an accumulated deficit of **$149.9 million**[135](index=135&type=chunk)[136](index=136&type=chunk) - Management believes existing cash will fund operating expenses and capital expenditure requirements through the **second quarter of 2024**[138](index=138&type=chunk) - The company has an "at-the-market" (ATM) offering program for up to **$75.0 million**. In 2021, it sold **4.8 million** shares for net proceeds of **$48.3 million**. No shares were sold under the ATM program in 2022[140](index=140&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is interest rate sensitivity on its cash, cash equivalents, and investments, which totaled **$85.9 million** as of September 30, 2022. Due to the short-term nature of these holdings, management believes a **100 basis point** change in interest rates would not have a material effect. The company also notes potential impacts from rising inflation on labor and program costs - The company's main market risk is interest rate sensitivity on its **$85.9 million** in cash and investments. A **1%** change in interest rates is not expected to have a material effect on fair market value[156](index=156&type=chunk) - Inflation is identified as a risk that could increase the cost of labor and clinical trials, potentially affecting business operations[156](index=156&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2022. There were no material changes in internal control over financial reporting during the quarter, despite many employees working remotely due to the COVID-19 pandemic - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[157](index=157&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal controls[160](index=160&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, comprehensive risk factors, and other miscellaneous disclosures relevant to the company's operations [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) A purported stockholder filed a class action complaint against the company and certain officers and directors on February 28, 2022, alleging false or misleading statements regarding the DesCAARTes™ Phase 1 clinical trial. This complaint was voluntarily dismissed by the plaintiff on October 17, 2022 - A securities class action lawsuit was filed against the company in February 2022 concerning disclosures related to the DesCAARTes™ trial[162](index=162&type=chunk) - The lawsuit was voluntarily dismissed by the plaintiff on October 17, 2022[162](index=162&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company outlines extensive risks related to its business, technology, and industry. Key risks include its early stage of development, the novel nature of its CAR T and CAAR T cell therapies, and the potential for serious adverse events like CRS and neurotoxicity. The company is highly dependent on the success of its initial product candidates (CABA-201, DSG3-CAART, MuSK-CAART) and faces challenges in clinical trial enrollment, manufacturing complexity, and reliance on third parties like the University of Pennsylvania. Financial risks include a history of net losses, the need for substantial additional funding, and potential stock price volatility. The company also highlights regulatory, intellectual property, and market competition risks - The company is in the early stages of development and its success is highly dependent on advancing product candidates through clinical trials and obtaining regulatory approval, which is a long and uncertain process[165](index=165&type=chunk) - Cellular therapies are a novel approach, and there is a risk of serious adverse events such as neurotoxicity and cytokine release syndrome (CRS), which could halt clinical development and negatively impact commercial potential[178](index=178&type=chunk) - The company has a history of net losses and anticipates incurring substantial losses for the foreseeable future, requiring significant additional financing to fund development and commercialization[261](index=261&type=chunk)[277](index=277&type=chunk) - The company relies heavily on in-licensed intellectual property and collaborations, particularly with the University of Pennsylvania (Penn) and IASO, and failure to maintain these agreements could severely harm the business[286](index=286&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=96&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities in the reported period[515](index=515&type=chunk) [Item 3. Defaults Upon Senior Securities](index=96&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were no defaults upon senior securities[516](index=516&type=chunk) [Item 4. Mine Safety Disclosures](index=96&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[517](index=517&type=chunk) [Item 5. Other Information](index=96&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - None[517](index=517&type=chunk) [Item 6. Exhibits](index=97&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including corporate governance documents, the exclusive license agreement with Nanjing IASO Biotherapeutics, and officer certifications - A list of exhibits filed with the Form 10-Q is provided, including the Exclusive License Agreement with Nanjing IASO Biotherapeutics Co., LTD., dated October 7, 2022[519](index=519&type=chunk)[520](index=520&type=chunk)

Cabaletta Bio° Corporate Presentation SEPTEMBER 2022 © 2022 Cabaletta Bio. All rights reserved. Disclaimer The following presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document or material distributed at or in connection with the presentation (collectively, the "Presentation") has been prepared by Cabaletta Bio, Inc. ("we," "us," "our," ...

Cabaletta Bio° Corporate Presentation AUGUST 2022 © 2022 Cabaletta Bio. All rights reserved. Disclaimer 2 The following presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document or material distributed at or in connection with the presentation (collectively, the "Presentation") has been prepared by Cabaletta Bio, Inc. ("we," "us," "our," " ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Non-accelerated filer ☒ Smaller reporting company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_______________ to _______________ Commission File Number: 001-39103 CABALETTA BIO, INC. (Exact Name of Regist ...

Cabaletta Bio° Corporate Presentation MAY 2022 © 2022 Cabaletta Bio. All rights reserved. Disclaimer 2 The following presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document or material distributed at or in connection with the presentation (collectively, the "Presentation") has been prepared by Cabaletta Bio, Inc. ("we," "us," "our," "Cab ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_______________ to _______________ Commission File Number: 001-39103 CABALETTA BIO, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State o ...

Cabaletta Bio° Corporate Presentation MARCH 2022 © 2022 Cabaletta Bio. All rights reserved. Disclaimer 2 The following presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document or material distributed at or in connection with the presentation (collectively, the "Presentation") has been prepared by Cabaletta Bio, Inc. ("we," "us," "our," "C ...

Cabaletta Bio° Corporate Presentation MARCH 2022 © 2022 Cabaletta Bio. All rights reserved. Disclaimer 2 The following presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document or material distributed at or in connection with the presentation (collectively, the "Presentation") has been prepared by Cabaletta Bio, Inc. ("we," "us," "our," "C ...

Part I [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements present Cabaletta Bio's financial position as of September 30, 2021, showing a net loss of **$32.4 million** for the first nine months of 2021 and increased cash and equivalents due to stock offerings [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of September 30, 2021, total assets increased to **$122.6 million**, driven by a rise in cash and cash equivalents to **$118.3 million**, while total stockholders' equity grew to **$116.6 million** Condensed Balance Sheet Data (in thousands) | Account | Sep 30, 2021 (Unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $118,260 | $101,429 | | Total current assets | $120,852 | $113,535 | | **Total Assets** | **$122,638** | **$114,724** | | **Liabilities & Equity** | | | | Total current liabilities | $6,023 | $5,180 | | Accumulated deficit | ($98,699) | ($66,298) | | Total stockholders' equity | $116,615 | $109,544 | | **Total Liabilities and Stockholders' Equity** | **$122,638** | **$114,724** | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the nine months ended September 30, 2021, the company reported a net loss of **$32.4 million**, primarily due to increased Research and Development costs of **$22.6 million** and General and Administrative expenses of **$9.8 million** Statement of Operations Highlights (in thousands) | Metric | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Research and development | $22,575 | $15,601 | | General and administrative | $9,845 | $8,902 | | **Total operating expenses** | **$32,420** | **$24,503** | | Loss from operations | ($32,420) | ($24,503) | | **Net loss** | **($32,401)** | **($24,030)** | | Net loss per share | ($1.31) | ($1.09) | [Condensed Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity increased to **$116.6 million** as of September 30, 2021, driven by common stock issuances that offset the **$32.4 million** net loss incurred - For the nine months ended September 30, 2021, the company issued common stock raising net proceeds of **$34.7 million** through its **ATM program** and an additional **$0.5 million** from stock option exercises[31](index=31&type=chunk)[82](index=82&type=chunk) - The accumulated deficit increased from **$66.3 million** at the end of 2020 to **$98.7 million** by September 30, 2021, due to ongoing net losses[31](index=31&type=chunk) [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2021, net cash used in operating activities was **$23.6 million**, while financing activities provided **$35.3 million**, resulting in a net increase in cash and cash equivalents of **$16.8 million** Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($23,594) | ($17,597) | | Net cash provided by (used in) investing activities | $5,150 | ($9,872) | | Net cash provided by (used in) financing activities | $35,275 | ($56) | | **Net increase (decrease) in cash** | **$16,831** | **($27,525)** | | Cash and cash equivalents—end of period | $118,260 | $108,679 | [Notes to Unaudited Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail Cabaletta Bio's clinical-stage focus on engineered T cell therapies, its high dependence on the **University of Pennsylvania (Penn)** for research and manufacturing, and its financial commitments and liquidity projections - The company is a clinical-stage biotechnology firm focused on developing engineered T cell therapies for B cell-mediated autoimmune diseases. It is highly dependent on the **University of Pennsylvania (Penn)** for preclinical research, clinical development, and initial manufacturing activities[36](index=36&type=chunk)[39](index=39&type=chunk) - Management expects that cash and cash equivalents of **$119.3 million** as of September 30, 2021, will be sufficient to fund operations for at least **12 months** from the filing date[41](index=41&type=chunk)[42](index=42&type=chunk) - The company has a sales agreement for an "**at-the-market**" (**ATM**) offering of up to **$75.0 million**. During the nine months ended September 30, 2021, it sold **3,606,005** shares for net proceeds of **$34.7 million**[82](index=82&type=chunk) - The company has committed to funding a research plan with **Penn** through February 2023 with a total estimated cost of **$12.3 million**, of which **$9.3 million** has been incurred as of September 30, 2021[67](index=67&type=chunk)[108](index=108&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing CAAR T cell therapies, its increased net loss of **$32.4 million** for the nine months ended September 30, 2021, driven by higher R&D expenses, and its liquidity supported by equity offerings [Overview](index=24&type=section&id=Overview) **Cabaletta Bio** is a clinical-stage biotech developing engineered T cell therapies for autoimmune diseases, with its lead candidate **DSG3-CAART** in a Phase 1 trial and **$119.3 million** in cash and investments as of September 30, 2021 - The company's lead product candidate, **DSG3-CAART**, is being evaluated in the Phase 1 **DesCAARTes™** trial for mucosal pemphigus vulgaris (mPV)[102](index=102&type=chunk) - The lead preclinical candidate, for **MuSK myasthenia gravis** (**MuSK MG**), is in IND-enabling studies with an IND submission planned for Q4 2021[102](index=102&type=chunk) - As of September 30, 2021, the company had **$119.3 million** in cash, cash equivalents, and investments, funded primarily by its **IPO** and **at-the-market** offerings[102](index=102&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Operating expenses increased for the nine months ended September 30, 2021, with R&D expenses rising by **$7.0 million** to **$22.6 million** and G&A expenses by **$0.9 million** to **$9.8 million**, leading to a net loss of **$32.4 million** Comparison of Operating Expenses for the Nine Months Ended September 30 (in thousands) | Expense Category | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Research and development | $22,575 | $15,601 | $6,974 | | General and administrative | $9,845 | $8,902 | $943 | | **Total operating expenses** | **$32,420** | **$24,503** | **$7,917** | - The **$7.0 million** increase in R&D expenses for the nine months ended Sep 30, 2021, was primarily driven by a **$2.8 million** increase in development services, a **$1.7 million** increase in personnel costs, and a **$1.5 million** increase in clinical trial costs for the **DesCAARTes™** trial[130](index=130&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$119.3 million** in cash, equivalents, and investments as of September 30, 2021, sufficient to fund operations through at least Q1 2023, but anticipates continued losses requiring substantial additional financing - As of September 30, 2021, the company had **$119.3 million** in cash, cash equivalents, and investments and an accumulated deficit of **$98.7 million**[134](index=134&type=chunk)[135](index=135&type=chunk) - The company believes its existing cash will fund operating expenses and capital requirements through at least the first quarter of 2023[137](index=137&type=chunk) - Through its **ATM Program**, the company sold **3,606,005** shares for net proceeds of **$34.7 million** during the nine months ended September 30, 2021, and an additional **600,000** shares for **$6.3 million** subsequent to the quarter-end[138](index=138&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$119.3 million** in cash and investments, but a **1%** change in rates is not expected to have a material effect due to their short-term, low-risk nature - The company's primary market risk is interest rate sensitivity on its **$119.3 million** of cash, cash equivalents, and investments[156](index=156&type=chunk) - Due to the short-term and low-risk nature of its investments, a **1%** change in interest rates is not expected to have a material effect on fair market value[156](index=156&type=chunk) - The company does not have any foreign currency or derivative financial instruments[157](index=157&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of September 30, 2021, the company's disclosure controls and procedures were effective at a reasonable assurance level[158](index=158&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[159](index=159&type=chunk) Part II [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) As of September 30, 2021, the company is not involved in any material litigation or legal proceedings expected to have a material adverse impact on its financial position - The company is not currently involved in any material legal proceedings[162](index=162&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including its early development stage, dependence on **DSG3-CAART** and the **University of Pennsylvania**, a history of losses requiring substantial funding, and complexities in manufacturing and intellectual property - The company is an early-stage clinical company with a limited operating history, dependent on the success of its initial product candidates, particularly **DSG3-CAART**[6](index=6&type=chunk)[164](index=164&type=chunk)[185](index=185&type=chunk) - The company is highly dependent on its relationship with the **University of Pennsylvania (Penn)** for preclinical R&D, technology, and clinical trial manufacturing[7](index=7&type=chunk)[331](index=331&type=chunk) - The company has incurred significant losses since inception and will need to raise substantial additional funding to complete development of its product candidates[6](index=6&type=chunk)[9](index=9&type=chunk)[257](index=257&type=chunk) - Manufacturing of the company's CAAR T cell product candidates is complex, novel, and susceptible to technical and logistical failures, with reliance on a limited number of third-party suppliers for key components like viral vectors[14](index=14&type=chunk)[360](index=360&type=chunk)[369](index=369&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=91&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities in the reported period[506](index=506&type=chunk) [Defaults Upon Senior Securities](index=91&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were no defaults upon senior securities[506](index=506&type=chunk) [Mine Safety Disclosures](index=91&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[506](index=506&type=chunk) [Other Information](index=91&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this period - None[507](index=507&type=chunk) [Exhibits](index=92&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including amendments to key agreements with the **University of Pennsylvania** and officer certifications - Filed exhibits include amendments to key agreements with the **University of Pennsylvania** and the Children's Hospital of Philadelphia, as well as required CEO and CFO certifications[510](index=510&type=chunk)

Cabaletta Bio° Corporate Presentation SEPTEMBER 2021 © 2021 Cabaletta Bio. All rights reserved. Disclaimer 2 The following presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document or material distributed at or in connection with the presentation (collectively, the "Presentation") has been prepared by Cabaletta Bio, Inc. ("we," "us," "our, ...